Cutaneous UlcerNCT06730022
Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
A study testing MTX-001 (Dermacyte Liquid) in people with Cutaneous Ulcer and Diabetic Ulcer, run by Merakris Therapeutics at 1 site in United States.
Trial summary
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Ulcer, Diabetic Ulcer, Surgical Wound Dehiscence
- What is being tested?
- MTX-001 (Dermacyte Liquid)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older
- Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator
Who cannot join
- Must not be pregnant or lactating
- Must not have known malignancies
- Must not be less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.
Read the detailed description
The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus, venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of quality of life, potential amputation, or mortality without efficacious treatment. As there are many types of patients who may be enrolled, study results will not have statistical significance.
- Conditions
- Cutaneous Ulcer, Diabetic Ulcer, Surgical Wound Dehiscence, Burns - Multiple, Pressure Ulcers, Mixed Ulcer
- Being tested
- MTX-001 (Dermacyte Liquid)
- Medical subject headings
- Skin Ulcer, Surgical Wound Dehiscence, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX-001 (Dermacyte Liquid)Drug
Repeat dose subcutaneous drug injection for the treatment of serious chronic wounds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Merakris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730022
- Sponsor's protocol ID
- DL-EAP-201
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
- ClinicalTrials.gov ID
- NCT06730022
- Acronym / sponsor ID
- DL-EAP-201
- Conditions
- Cutaneous Ulcer, Diabetic Ulcer, Surgical Wound Dehiscence, Burns - Multiple, Pressure Ulcers, Mixed Ulcer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Merakris TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.
Detailed description
The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus, venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of quality of life, potential amputation, or mortality without efficacious treatment. As there are many types of patients who may be enrolled, study results will not have statistical significance.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be 18 years of age or older
- Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator
Key exclusion criteria (3 listed)
- Must not be pregnant or lactating
- Must not have known malignancies
- Must not be less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX-001 (Dermacyte Liquid)Repeat dose subcutaneous drug injection for the treatment of serious chronic wounds. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTX-001 (Dermacyte Liquid) in people with Cutaneous Ulcer and Diabetic Ulcer, run by Merakris Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean O'Connell, PhD Scientic & Medical Affairs Scientist (973-214-0837, seano@merakris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.